Gluten ID Test for Celiac Disease Risk

Test Introduction

GLUTEN ID^® is a celiac genetics health risk screening test designed for individuals, families, and populations. GLUTEN ID is developed and optimized by ResearchDx scientists and performed by Next-Generation sequencing (NGS) for detection of variants in the HLA-DQA1, DQB1 genes linked to celiac genetic risk haplotypes. All celiac genetic risk DQ2, DQ8 haplotypes supported by Level I (the highest) Level of Evidence (LOE) are covered by the test. If none of the celiac risk-associated GLUTEN ID haplotypes are detected the result is reported as non-celiac genetics which has greater than 99% negative predictive value (NPV) for the development of celiac disease. Cheek swab samples for GLUTEN ID can be collected non-invasively at home or in a physician’s office with results reported within 14 days. For more information about ordering this test, visit: targeted-genomics.com

Test Description

How GlutenID™ Works

GlutenID™ analyzes HLA genetic markers associated with celiac disease risk, including DQ2, DQ8, DQ2.2, and DQ7. These markers are tested using our proprietary next-generation sequencing (NGS) genotyping process. Genotypically, these genes are present in nearly 100% of celiacs. A negative test result may ‘rule-out’ celiac disease whereas a positive result should be followed with additional diagnostic testing to confirm a celiac disease diagnosis. Results should be interpreted in the context of the patient’s clinical and laboratory findings.

Test Summary:

At-home saliva collection makes testing easy and accessible.
Results are reported on a spectrum of risk, helping users understand their likelihood of developing celiac-related gluten sensitivity.
Negative results (Non-Celiac Genetics, or NCG) indicate a less than 1% lifetime risk of developing celiac disease.
Each user receives one of 15 possible genetic profiles (GlutenIDs), providing clarity on their inherited risk.

Why Genetic Testing for Celiac Disease Matters

Celiac disease is an autoimmune disorder triggered by gluten consumption, affecting millions worldwide. While environmental factors play a role, genetics is the root cause. Understanding genetic predisposition can:

Dr. Shelly Gunn, Founder and Medical Director of Targeted Genomics, emphasizes the importance of accessibility:

“Celiac genetics can be complex—even for physicians. GlutenID™ simplifies testing and interpretation, empowering individuals to understand their inherited risk and take proactive steps toward wellness.”

The GlutenID^® report will contain one of the following Possible test results:

GlutenID^®	Estimated Risk	Risk Category
DQ2+DQ2	1 in 9 (11%)	Increased Risk
DQ2+half-DQ2	1 in 9 (11%)	Increased Risk
DQ2+DQ8	1 in 12 (8%)	Increased Risk
DQ8+half-DQ2	1 in 25 (4%)	Increased Risk
DQ2+DQ7	1 in 35 (3%)	Increased Risk
DQ2.2+DQ7 (DQ2 trans)	1 in 35 (3%)	Increased Risk
DQ2(cis)	1 in 35 (3%)	Increased Risk
DQ8+DQ8	1 in 100 (1%)	Low Risk
DQ8	1 in 100 (1%)	Low Risk
DQ8+DQ7	1 in 100 (1%)	Low Risk
half-DQ2+half-DQ2	1 in 210 (0.5%)	Not Likely At Risk
half-DQ2 (DQ2.2)	1 in 210 (0.5%)	Not Likely At Risk
DQ7+DQ7	1 in 1842 (0.05%)	Not Likely At Risk
DQ7	1 in 1842 (0.05%)	Not Likely At Risk
Non-Celiac Genetics	1 in 2518 (0.05%)	Not Likely At Risk

Test Ordering

GlutenID™ is available for purchase directly through the Target-Genomics website. Testing is performed at PacificDx. This FDA-cleared at-home genetic health risk test makes it easier than ever to understand your genetic predisposition to celiac disease and make informed health decisions.

Order Your Test Today

The GlutenID® test uses qualitative genotyping to detect clinically relevant variants in genomic DNA collected from saliva cells for the purpose of reporting and interpreting celiac genetic health risk (GHR). This test provides genetic risk information about specific genetic variants but does not report on a User’s entire genetic profile. Other companies offering a celiac genetic risk test may detect different genetic variants for the same disease so the User may receive different results from another company. This test is not intended to diagnose celiac disease. Other factors such as lifestyle and ethnicity my affect celiac disease risk. Some people may feel anxious about getting genetic test results. This is normal. Talk with your healthcare provider or a genetic counselor about genetic testing. The celiac GHR report describes if a person has variants associated with a higher risk of developing celiac disease but does not describe a person’s overall risk of developing the disease. The test is not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment. Warnings & Limitations: This test does not include variants in other genes linked to celiac disease and the absence of variants included in this report does not rule out the presence of other genetic variants that may impact celiac risk. The GlutenID® test is not a substitute for visits to a healthcare professional for recommended screenings or appropriate follow-up. Results should be confirmed in a clinical setting before taking any medical action. The intended use of the GlutenID® Test does not include prenatal testing, cancer predisposition, pharmacogenomic assessment, or determination of autosomal dominant genetic variants. For important information and limitations regarding genetic health risk reports, visit review the package insert.

Sample Collection and Shipping Instructions

GlutenID™ is available for purchase directly through the Target-Genomics website. The test kit contains all required materials for at home collection and shipping the kit to PacificDx for analysis. This test is FDA cleared. This assay has been validated by PacificDx pursuant to the CLIA regulations and is used for clinical purposes.